- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01732952
Dyslipidemia International Survey-China (DYSIS-China)
Dyslipidemia International Survey - China
This cross-sectional, non-interventional, and observational study will assess the lipid profile of patients who have been taking lipid-modifying drugs (i.e., proportion of patients achieving treatment to goal according to national and international lipid management guidelines) during a single visit to their physicians on an outpatient basis in 6 representative geo-economic regions in China: Northeast, North, East, South, Southwest, and Northwest; and within each region, in three tiers of hospitals: tier 3 (primary or teaching hospitals), tier 2 (secondary or city level hospitals), and tier 1 (community hospitals/health centers). The investigators will primarily be cardiologists, endocrinologists, neurologists, gerontologists, internists, or other physicians who are representative of the general population of physicians managing patients with dyslipidemia and/or at high risk for cardiovascular events likely to be treated with lipid-modifying drugs. Demographic data, cardiovascular risk factors, a history of cardiovascular disease and cardiovascular treatments will be documented in a single visit through patient clinical examination and chart review.
DYSIS-China is part of a string of epidemiological studies that share the same master protocol, which has been conducted in different countries mainly in Europe and Canada. The analysis of the pooled studies including overall data and cross-country comparisons is the subject of a distinct protocol.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100044
- Reclutamiento
- Peiking University People' Hospital
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Contacto:
- Ding Rong Jing, Dr.
- Número de teléfono: 0108688325940
- Correo electrónico: drj2003@sina.com
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Sub-Investigador:
- Ding rong jing, Dr.
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
- Patient is an outpatient > 45 years of age
- Patient is currently* treated with a statin
- Patient has a documented fasting lipid profile (> 1 lipid parameter within the last 12 months) performed while on lipid-modifying therapy for at least 3 months
Patient agrees to participate in the study by giving informed consent.
- Patient is already being treated with a lipid-modifying drug just before the visit. Patient for whom a lipid-modifying therapy is initiated at the time of the visit must not be included.
Descripción
Inclusion Criteria:
- Patient is an outpatient > 45 years of age
- Patient is currently* treated with a statin
- Patient has a documented fasting lipid profile (> 1 lipid parameter within the last 12 months) performed while on lipid-modifying therapy for at least 3 months
Patient agrees to participate in the study by giving informed consent.
- Patient is already being treated with a lipid-modifying drug just before the visit. Patient for whom a lipid-modifying therapy is initiated at the time of the visit must not be included.
Exclusion Criteria:
1. Patient is currently participating in a clinical trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
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regions,hospitals,age, gender, risk levels, comorbidity,
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
the prevalence and types of persistent lipid abnormalities in patients aged > 45 years treated with a lipid-modifying drug
Periodo de tiempo: 6 months
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6 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
assess patient characteristics, including CV risk levels, in the subsets of patients with persistent lipid abnormalities
Periodo de tiempo: 6months
|
6months
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
---|---|
explore a potential relationship between the persistence of lipid abnormalities and the local known (historical) prevalence of CV morbidity/mortality
Periodo de tiempo: 6months
|
6months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hu da yi, Dr., Chinese Society of Cardiology
Publicaciones y enlaces útiles
Publicaciones Generales
- Chen Y, Yin C, Li Q, Yu L, Zhu L, Hu D, Sun Y. Misuse of Aspirin and Associated Factors for the Primary Prevention of Cardiovascular Disease. Front Cardiovasc Med. 2021 Sep 3;8:720113. doi: 10.3389/fcvm.2021.720113. eCollection 2021.
- Yan X, Li Y, Dong Y, Wu Y, Li J, Bian R, Hu D. Blood pressure and low-density lipoprotein cholesterol control status in Chinese hypertensive dyslipidemia patients during lipid-lowering therapy. Lipids Health Dis. 2019 Jan 29;18(1):32. doi: 10.1186/s12944-019-0974-y.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0000-271-0
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